Notice2026-17675
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 31, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with reports of removals and corrections for medical and radiation emitting products regulated by FDA's Center for Devices and Radiological Health (CDRH).
Full Text
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<title>Federal Register, Volume 91 Issue 167 (Monday, August 31, 2026)</title>
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[Federal Register Volume 91, Number 167 (Monday, August 31, 2026)]
[Notices]
[Pages 55859-55861]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17675]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-9349]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Reports of Removals and Corrections
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with
reports of removals and corrections for medical and radiation emitting
products
[[Page 55860]]
regulated by FDA's Center for Devices and Radiological Health (CDRH).
DATES: Either electronic or written comments on the collection of
information must be submitted by October 30, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 30, 2026. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2026-N-9349 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices; Reports of
Removals and Corrections.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Barrett, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#a4f4f6e5f7d0c5c2c2e4c2c0c58accccd78ac3cbd2"><span class="__cf_email__" data-cfemail="6c3c3e2d3f180d0a0a2c0a080d4204041f420b031a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Medical Devices; Reports of Corrections and Removals--21 CFR Part 806
OMB Control Number 0910-0359--Extension
This information collection supports implementation of provisions
of section 519(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(g)) requiring device manufacturers and importers to report
promptly to FDA certain actions concerning device corrections and
removals and to maintain associated records. Applicable regulations are
found in 21 CFR part 806 and set forth definitions, prescribe format
and required content elements for reporting, and identify actions that
are exempt from the reporting requirements. The information collected
is used by FDA to identify marketed devices that have serious problems
and to ensure that defective devices are removed from the market. The
[[Page 55861]]
information also helps ensure that FDA has current and complete
information regarding these corrections and removals to determine
whether recall action is adequate.
Reports of corrections and removals may be submitted to FDA by
mail, email, or using FDA's Electronic Submission Software
(eSubmitter). To assist respondents with submitting reports of
corrections or removals, we developed Form FDA 5072, ``Device
Correction/Removal Report for Industry,'' a fillable PDF. Reports
created using eSubmitter are transmitted to CDRH through FDA's
Electronic Submission Gateway (ESG). Instructions for the completing
Form FDA 5072 are provided in pop-up text boxes that appear over each
data field. We expect that use of the fillable form will expedite
processing of the reports of corrections or removals submitted to FDA.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Total
Number of Number of Total Average Total operating &
21 CFR; IC activity Form respondents responses per annual burden per hours maintenance
respondent responses response \1\ costs
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Electronic process setup................. ........................... 463 1 463 3.08 1,426 $23,150
806; device product corrections or FDA Form 5072: ``Device 925 1 925 10 9,250 ..............
removals. Correction/Removal Report
for Industry''.
4.102; combination product corrections or ........................... 20 1 20 10 200 ..............
removals (including sharing information
with other constituent part applicants
under 4.103).
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Total................................ ........................... ............ .............. 1,408 ........... 10,876 23,150
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\1\ Figures rounded.
For respondents who submit corrections and removals using the ESG,
the operating and maintenance costs associated with this information
collection are approximately $50 per year to purchase a digital
verification certificate (certificate must be valid for 1 to 3 years).
This burden may be reduced if the respondent has already purchased a
verification certificate for other electronic submissions to FDA.
Table 2--Estimated Annual Recordkeeping Burden
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Number of Total
21 CFR; IC activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours \1\
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806.20; device product 110 1 110 10....................... 1,100
corrections and removals.
4.105; device-led combination 279 1 279 .5 (45 minutes).......... 140
products \1\.
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Total..................... ............... .............. 389 ......................... 1,240
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Figures rounded.
Our estimated burden for this information collection reflects an
overall decrease of 833 hours, with a corresponding decrease of 162
total annual responses and an increase of 170 total annual records. We
attribute this adjustment to a decrease in the number of device
correction and removal reports received over the last few years, which
has reduced our reporting burden estimate from 1,033 to 925 respondents
under 21 CFR part 806. This decrease in reporting burden is partially
offset by an increase in recordkeeping burden, driven by a revised
estimate of records per recordkeeper for device-led combination
products under 21 CFR 4.105 and a modest increase in the number of
device correction and removal recordkeepers. The estimated Operating
and Maintenance Costs associated with electronic process setup has
decreased by $2,700 as a result of fewer respondents expected to
purchase a digital verification certificate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17675 Filed 8-28-26; 8:45 am]
BILLING CODE 4164-01-P
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